Announcing the Long Awaited Malaria Vaccine as GSK Records Breakthrough!

September 8, 2015September 8, 2015 by PharmaTimes

For many years running until now, the world has had to confront the dreaded disease of the tropics transmitted through the bite of a tiny insect vector – the Mosquito. Malaria aside, researchers and scientists worldwide have had to confront so many other health issues, some of them relatively new, with the bid to finding lasting solutions by way of vaccine production. There is no gain saying the fact that a lot of successes have been attained over the decades; but the world has also waited patiently for thirty years since deliberate and concerted efforts began towards finding a lasting solution to the bugging malaria question. As the world rejoices over the approval of the first ever malaria vaccine made possible by pharmaceutical giants – GSK, Health editor, MORGAN NWANGUMA, traces the long history and issues of malaria to the eventual discovery of the vaccine called Mosquirix.

The endemic zones

In the days of yore prior to the entrenchment of colonialism on the continent of Africa, most of what is known today as West Africa and indeed most of the tropics had always seen the natives live in precarious times and circumstances mostly in typical forest and humid environs. The tropics are actually the terrains lying on the earth’s surface between the Tropic of Cancer and the Tropic of Capricorn; these portions of the globe are usually characterised by a hot climate. Also the setting for a typical tropical region and climate is one usually characterised by warm to hot and moist year-round, often with the sense of lush vegetation; this is also a happy home for mosquitoes.

Most of the tropical zones have a dry and wet season built into them. The wet season or green season which we refer to in Nigeria as rainy season, is the time of year, running through a period of about three months, when most of the average annual rainfall in a region falls. But when the rainy season runs into or occurs during the warm season, or summer, rainfall is likely to be experienced mainly during the late afternoon and early evening hours. The rainy season is also a time when the air quality improves; there is the evidence of freshwater quality improvement and there is a flourishing or growth of vegetation, leading to increased crop yields late in the season.

Weather and climate

In the tropics, during the wet season, floods would normally cause rivers to overflow their banks; wildlife will equally be disturbed as some will be rendered homeless while some animals will be forced to retreat to higher ground. In the midst of all these you are bound to find some sources of stagnant water as well such as in ponds, poodles, gutters, swamps, and stored up water in containers in living habitations. These are the favourite breeding grounds for mosquitoes. Soil nutrients diminish and erosion increases.

Over time, scientific research has shown that the incidence of malaria increases in areas where the rainy season coincides with high temperatures. Animals have adaptation and survival strategies for the wetter regime. Unfortunately, the previous dry season leads to food shortages into the wet season, as the crops have yet to mature. But again, historically nature has always triumphed over adversities; the indigenous people had learnt to survive even the hard way – always adapting to their environment and instinctively proffering solutions to problems that are equally native to them including living with the mosquitoes.

The Tropics

But life in the tropics has never been easy by any means. In trying to weather some of the many storms of the forest region, traditional settings in these places, be they in India, West Africa or down to the forests of the Amazon of South America, one big obstacle has always confronted the inhabitants of the tropics: Ordinarily, mosquitoes would not have made the headlines as they have since malaria was recognised globally as a health blight through massive public awareness campaign, if not perhaps for the role of the female anopheles mosquito. The female anopheles mosquito is the one that is known to bite and suck the blood of its victims – human beings.

As the victim is bitten by the female anopheles mosquito, it at the same time transmits the parasite responsible for the infection of malaria i.e. the plasmodium parasite. After about seven or more days of incubation the victim falls sick with malaria encumbered with paroxysms of chills and fever; weakness, aches and pains amongst other symptoms; experts say this is of course depending on the level or lack of immunity of the individual so bitten. Malaria has always been a scourge on the population of these regions for centuries and especially regarding the rural populations. But in an attempt to deal with the situation, the people of the tropics have also from the very beginning had ways of combating this infective disease by what might be termed native intelligence.

Roots, herbs and all manner of concoctions have been devised in the bid to find remedy for the all year round epidemic. Herbalists, native doctors and witch doctors alike have all been in the fray to cage the ravaging malaria menace until the advent of western medicine if you will. But have all of these concerted efforts been in futility? Maybe, maybe not; but the general consensus would be that it has all been frustrating all the while; one could say though it has been a losing battle most of the time.

But the battle against malaria in the tropics probably gained a more international stature in the days of colonialism in West Africa for instance. No matter how awful the battle has been, at least the indigenous people were somewhat adapted to living in the circumstances – surviving in the midst of it in the rain forests, and in the heat of the sun. But history tells us that there was once a place – this same territory that the world came to know as the Whiteman’s grave. That was West Africa! Thus Malaria killed the fair-skinned strangers in droves, and the forests became mass graves for the invading slave raiders, and later – colonialists.

The battle against Malaria

In the course of the introduction of western education and western medicine till date, malaria had for long taken the centre stage of global health intervention measures including funding for research and development, procurement of drugs, provision of insecticides, mosquito nets, and also the possibility of achieving a malaria vaccine. And then within the past decade or so in addition to all the intervention measures, with the help of World Health Organisation, insecticide treated mosquito nets have also been in vogue.

Yet recent research studies have proven that even in the presence of the relatively new dreaded killers of the human species such as HIV/AIDS, Cholera, Tuberculosis, Cancer, etc, malaria has remained as claimed by most health experts, the biggest singular killer disease today. WHO records have it that Malaria killed an estimated 584,000 people in 2013 alone; the vast majority of them being in the sub-Saharan Africa region, including the fact that more than 80 percent of malaria related deaths have been in children that are aged below five years.

Thus the battle to conquer this dreaded killer of the human race has long been on-going, and on all fronts. Many have been in the good race to cage this monster that is transmitted by a tiny annoying insect. Malaria has over time rendered individuals and communities of able bodied men and women including children powerless, depriving them of both physical and economic wellbeing; farmlands are left desolate due to the weakening effects of the parasite while many families are thrown into mourning over its life destructive effects.

But at long last, after a whopping expenditure of $356 million in the course of carrying out 30 years of gruelling research, British drug giants – GlaxoSmithkline has just recently won approval from European safety regulators for the world’s first malaria vaccine! This landmark achievement which is coming to avail so much relief to the world and especially people living in the tropics, has been a long time coming.

First ever Malaria Vaccine

And so the new product, Mosquirix vaccine has been approved for use and is about to commence or undertake a trial mission by the European Medicines Agency (EMA). The experts say it is certified safe to use among children in Africa which is where we have had most of the malaria deaths so far. The vaccine, Mosquirix which is also referred to as RTS,S would be the first licensed human vaccine against a parasitic disease and is very likely to help prevent millions of cases of malaria in countries that will eventually put it to use.

But the fact is that Mosquirix will not be rolling out as at yet perhaps until 2016 even though the manufacturers have already in stock tens of millions of doses of the vaccine. This is because it still has to get approval from the World Health Organisation which will give its guidance on when and where it should be used towards the end of this year or early 2016.

Speaking later on in a statement, GSK’s chief executive, Andrew Witty said EMA’s positive recommendation was a further important step towards making the world’s first malaria vaccine available and accessible for little children. “While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most,” he also said.

The vaccine however, experts say will not be licensed for travellers yet.

Mosquirix works by activating the immune system to defend against the first stages of infection by the Plasmodium falciparum parasite after it has gone into the bloodstream following a mosquito bite. It will of course also need to get the green light from the African nations where the vaccine could be put to use first. According to experts, this is just a vaccine and not a drug for the cure of malaria, but the good news is that once a child is immunised with the vaccine and the system completely accepts it, there is an assurance of round-the-clock protection.

So far human trials have revealed that Mosquirix prevented only about half of malaria cases among children aged between 5 months and 17 months – being the best results achieved, while only about a quarter was successful among babies aged between 6 weeks and 12 weeks old. This has been the only disappointment for the team of researchers, and a dilemma for WHO in that the vaccine has not worked perfectly in the manner scientists had expected. But even at that, head of research at GSK vaccines, Dr. Ripley Ballou, in his statement saw the development as a “hugely significant moment”, reiterating that the vaccine has been in the works for 30 years.

For the older babies (5-17 months old), the children were each administered 3 doses of the vaccine a month apart, including a booster dose at 20 months. With this group experts were able to achieve in 4 years, a 1/3 reduction in cases of severe malaria. However, the effectiveness of the vaccine waned over time, making the booster shot essential, because without it, the vaccine did not cut the rate of severe malaria over the trial period.

The Mosquirix vaccine was produced by GlaxoSmithkline in partnership with the PATH Malaria Vaccine Initiative, and through funding made possible by Bill and Melinda Gates Foundation. Sources say that GSK will only charge 5 percent margin for the product above its manufacturing cost, which will also be re-invested into further vaccine research.